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The market can produce skewed information about investigational products awaiting FDA approval. But the FDA rarely steps in to correct such misleading information, despite statutory authority to do so. This article evaluates a recommendation by the FDA Transparency Working Group that FDA more clearly signal when and how it will correct misleading information about investigational products, and why such a recommendation is particularly important after the 21st Century Cures Act.

Given the novelty of digital health technologies, there remains significant confusion over which laws and regulations might apply to these technologies, and how. This chapter describes the major bodies of state and federal law that can apply, including medical device regulation by the FDA, state and federal consumer protection laws, data privacy and security laws, and potential legal liability for physicians, hospitals, manufacturers, and developers. The chapter examines how awkwardly these laws have adapted to the novel features of digital health, and vice versa. It concludes by detailing how, in the absence of quality screening by the FDA, four alternative methods of quality screening have emerged, including (1) due diligence by venture capital firms, (2) hospital guidelines for users and developers, (3) review by third-parties, such as app review web sites, and (4) coverage policies by health insurers. I call these “surrogate” or “proxy” regulation.

The Federal Food, Drug, and Cosmetic Act (FDCA) does not expressly prohibit companies from marketing or promoting drugs for unapproved, "off-label" uses. The FDA itself acknowledges that off-label promotion is not a "prohibited act" under the statute, or an element of any such act. Instead, the FDA uses off-label promotion as evidence of other statutory violations. This Article engages in perhaps the most thorough statutory construction analysis of the FDCA on this question, finding that the statute does support the FDA's functional ban on off-label promotion. Using various tools of construction, I find that several sections of the FDCA assume or expressly contemplate a ban on off-label promotion, and that the FDCA's regulation of medical products, as a whole, depends on such a ban.

This Report, prepared for the Administrative Conference of the United States (ACUS), details how federal agencies use modern forms of publicity - including press releases, agency web sites, searchable online databases, and social media - to achieve regulatory ends. It evaluates the benefits and burdens of modern agency publicity practices, using three agencies as case studies: the Food and Drug Administration (FDA); the Federal Trade Commission (FTC); and the Consumer Financial Protection Bureau (CFPB). Part V recommends a series of largely procedural reforms that balance the need for public disclosure with the need to protect those potentially injured by adverse agency publicity. This Report formed the basis for Administrative Conference Recommendation 2016-1, Consumer Complaint Databases, adopted at the June 10, 2016 Plenary Session. See 81 Fed. Reg. 40249 (Jun. 21, 2016).

Mobile health (“mHealth”) is the use of portable devices such as smartphones and tablets to improve health. This report discusses the public health benefits and risks of mHealth and the challenges facing the FDA in regulating this technology.

Disruption theory tells us that certain innovations can undermine existing products, firms, or even entire industries. Classic examples include the Kodak camera, the Bell telephone, and the Ford Model T. Modern examples abound. The market entrant’s innovation ultimately displaces industry incumbents. Regulators, too, are challenged by such disruptive innovations. The new product, technology, or business practice may fall within an agency’s jurisdiction but not square well with the agency’s existing regulatory framework. Call this “regulatory disruption.”Most scholars intuit that regulators should be cautious rather than firm in such situations. Tim Wu, in Agency Threats, argues that agencies confronting disruptive innovations should avoid traditional rulemaking and adjudication, and instead rely on “threats” packaged in guidance documents, warning letters, and the like. Threats, he argues, are less burdensome, more flexible, and avoid regulation that is miscalibrated or premature. However, this Article argues that a flexible initial posture based primarily on “threats” can calcify, creating weak defaults that lead to suboptimal regulation in the long term. Regulatory inertia can be hard to break without an external shock, usually a tragedy or some other massive failure that reignites interest in regulation. As a case study, this Article shows how the FDA’s approach to a disruptive technology (computerized medical devices) twenty-five years ago fits the threat framework strikingly well, and how it failed. The FDA’s threats became stale and counterproductive — during a profound computer revolution, no less. This Article counterposes the FDA’s approach to software with the FCC’s approach to the Internet, which initially relied on threats, but later codified them via binding regulations and enforcement shortly thereafter.This Article argues that agencies need not be so tentative with innovations. If agencies are concerned about regulating prematurely or in error, then they can experiment with timing rules, alternative enforcement mechanisms, and other variations on traditional interventions. If agencies do choose to proceed by making threats, then they should use them as a short-term precursor to more decisive, legally binding action, as the FCC did, and avoid relying on them as a long-term crutch, as the FDA did.

What role does market competition play in the United States’ health care system, and what might the United States (US) and the European Union (EU) learn from each other’s experiences? Market competition remains a persistent but elusive ideal in American health care.

Compared with conventional small-molecule drugs, products derived from a biological source are structurally complex and involve manufacturing processes that require tight control to ensure their safety, quality, and efficacy. Because of these differences in respect of the product characteristics and manufacturing process, the regulatory supervision of biological products is distinguishable from conventional pharmaceutical products based on small molecules. This article addresses legal framework governing biological products in Japan, the United States, and the European Union. Keywords: rules and legislation; food and drug administration (FDA); biopharmaceuticals; biological products; european union (EU)

Rarely does a class of technologies excite physicians, patients, financeers, gadgeteers, and policymakers alike. But mobile health — the use of mobile devices like smartphones and tablets for health or medical purposes — has captured our collective imagination. Observers predict that mobile health, also referred to as “mHealth” or “medical apps,” can save millions of lives, billions in spending, and democratize access to health care. Proponents argue that mobile health technologies will transform the ways in which we deliver, consume, measure, and pay for care; disrupting our sclerotic health care system.This Article evaluates mobile health and its many ambitions. Given the significant hype surrounding mobile health, I try to provide a relatively sober, dispassionate review of the many claims here. I begin by surveying the universe of mobile health technologies, offering a typology of products based on their functions, many of which have regulatory significance. The Article then considers the federal government’s posture towards mobile health. To date, Congress and over half a dozen federal agencies have addressed mobile health. Contrary to the prevailing wisdom, federal regulators are sympathetic, not hostile, to these technologies. However, I demonstrate how one agency, the U.S. Food and Drug Administration (FDA), is repeating the same mistakes that it made when it first confronted medical device software 25 years ago, relying on nonbinding guidance documents that are largely weak and unenforceable. I argue that, somewhat counter-intuitively, mobile health will only reach its immense potential if regulators like the FDA provide meaningful oversight. Otherwise, users will be flooded with mobile technologies that are ineffective, or worse, unsafe.

For over a century, the Food and Drug Administration (FDA or the Agency) and its precursors have regulated what companies say about their products. The FDA itself notes that the regulatory scheme imposed by the Federal Food, Drug, and Cosmetic Act “depends on the use of words” and that its requirements can “explicitly limit speech.” For seventy years, the FDA had little reason to worry about First Amendment constraints. But since 1976, when the Supreme Court reversed its longstanding position that the First Amendment does not protect commercial speech, the Agency has had to confront–perhaps more than any other federal agency–the free speech rights of regulated firms.But how far do those rights extend, and what room do they leave for regulators like the FDA? The answer largely depends on another question: Is the speech commercial or noncommercial? The distinction is paramount. If speech by a regulated firm is commercial, then the FDA can ensure that it is not false or misleading; the Agency can require or compel certain speech; it can impose prior restraints; and it can even limit truthful speech, all within certain parameters.